Analysis of the Postprandial Effects of a Vegetable Protein Mixture Rich in Arginine, Cysteine and Leucine on Endothelial Dysfunction and Inflammation at Low Noise in Elderly People With Cardiometabolic Risk (P-PROBS CM)

By 2050, the expanding world population will consume two-thirds more animal protein than it consumes today. The increase in chronic diseases associated with the generalization of these consumption patterns tend to understand the place of meat in our diets. All these elements participate to the reduction of animal proteins in favor of vegetable proteins in our food. The elderly are particularly affected by malnutrition, the prevalence of protein-energy malnutrition increasing with age and promoting the onset of morbidities. Without care, it leads to the worsening of physiological phenomena linked to aging such as loss of muscle functionality (sarcopenia) or reduction in bone density (osteoporosis) and increases the risk of falls - the main cause of dependence. However, in France, protein consumption declines significantly with age, even though requirements appear to be greater for the elderly. It is therefore a major challenge for our societies to ensure that the aging of the population and the increase in life expectancy are not synonymous with a reduction in the physical and mental capacities of individuals. Thus, it is essential to ensure that the recommendations for reducing the intake of animal proteins in favor of vegetable proteins can be applied without risk to aging populations, in particular on the human body cardiovascular risk of these populations.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Predisposition to Cardiovascular Disease
• Intervention / Treatment: Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; Behavioral: Animal proteins (AP); Behavioral: No protein (T)

Detailed Description

This human dietary intervention study is a double blind, randomized, placebo controlled, cross over trial with 3 arms, carried out on subjects with predisposition to cardiometabolic syndrome (based on weight circumference, blood triglyceride or blood cholesterol, glycemia and hypertension). This study aims to demonstrate transient improvement in vascular endothelial function (with Flow Mediated Dilatation (FMD) as main criteria) with consumption of vegetable proteins (rich in leucine, cysteine and arginine) by comparison with animal proteins and with a control without proteins.

The 33 recruited participants will receive the 3 yogurts in a random order. For each subject, the study is divided into 4 visits.

To summarize: Visit 1 (D-7) = inclusion, Visit 2 (D0: treatment period N°1), Visit 3 (D28 : treatment period N°2), Visit 4 (D56 : treatment period N°3). The wash-out periods between treatment period (duration: 4 weeks) may be extended until 5 weeks for the convenience of participants.

The protocol includes a total of 4 visits to PIC/CIC Inserm 1405 of the Clermont-Fd University Hospital.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Man or woman
• 65 years old and older (inclusive)

• At least 2 of the following 4 cardiometabolic factors:

  • Waist circumference ≥88 cm for women, and ≥94 cm for men
  • Fasting triglyceridemia >1,5 g/L OR HDL level < 40 mg/dl for men, and < 50 mg/dl for women
  • Fasting blood glucose ≥ 100 mg/dl
  • Systolic blood pressure >130mmHg ou diastolic > 85 mm Hg
• Accept not to change his lifestyle throughout the study
• Accept to consume the same meal the day before exploration days, making sure to exclude non-recommended foods and agreeing to detail its content in a food diary
• Ability to give informed consent to participate in research
• Affiliation to Social Security

Exclusion Criteria:

• Acute pathology (unstable or terminal pathology)
• Renal failure (clearance <40 mL / min)
• Asthma or chronic respiratory disease
• Systolic or diastolic blood pressure in the judgement of the investigator
• Diabetic (treated or not)
• Treated with chemotherapy
• Gastrointestinal, thyroid, cardiac or vascular illness in the judgement of the investigator
• Biological examination no compatible with the study in the judgement of the investigator
• Medical and/or surgical history no compatible with the study in the judgement of the investigator (previous cardiovascular events)
• AgHbS, AcHbc, HCV and HIV positive serology
• Concomitant treatment no compatible with the study in the judgement of the investigator
• Diet or change in body mass > 2 kg in the 30 days before the study
• Following a diet incompatible with the nutritional protocol (food intolerances, vegans, exclusion of certain food ingredients)
• Allergies to any of the components of the test meals
• Alcohol consumption> 2 glasses / day
• Current smokers (> 6 cigarettes per week)
• Subjects involved in another clinical trial or being in the exclusion period of another study or having received a total compensation greater than 4,500 euros over the 12 months preceding the start of the trial
• Subject benefiting from a legal protection measure (curatorship, guardianship, safeguard of justice)
• Refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group/Cohort1; 33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in cysteine, leucine and arginine (VP, vegetable proteins) only once during the visit	Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; 33 volunteers will consume 400 ml of yogurt with vegetable proteins (VP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of vegetable proteins.; Behavioral: Animal proteins (AP); 33 volunteers will consume 400 ml of yogurt with animal proteins (AP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.; Behavioral: No protein (T); 33 volunteers will consume 400 ml of yogurt without any protein (T) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
Experimental: Group/Cohort2; 33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in animal proteins (AP) only once during the visit	Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; 33 volunteers will consume 400 ml of yogurt with vegetable proteins (VP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of vegetable proteins.; Behavioral: Animal proteins (AP); 33 volunteers will consume 400 ml of yogurt with animal proteins (AP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.; Behavioral: No protein (T); 33 volunteers will consume 400 ml of yogurt without any protein (T) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
Placebo Comparator: Group/Cohort3; 33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit	Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; 33 volunteers will consume 400 ml of yogurt with vegetable proteins (VP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of vegetable proteins.; Behavioral: Animal proteins (AP); 33 volunteers will consume 400 ml of yogurt with animal proteins (AP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.; Behavioral: No protein (T); 33 volunteers will consume 400 ml of yogurt without any protein (T) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized.	Day 0 (V1) at T-30min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 0 (V1) at T180min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 0 (V1) at T300min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 28 (V2) at T-30min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 28 (V2) at T180min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 28 (V2) at T300min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 56 (V3) at T-30min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 56 (V3) at T180min
Brachial artery Flow Mediated Dilation (FMD)	The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery. FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.	Day 56 (V3) at T300min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rest flow by Flowmetry Laser Doppler (FLD)	Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the rest flow using laser-Doppler system at the level of the skin of the hand realized between T-30min to T300min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Occlusion area by FLD	Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the occlusion area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Hyperaemia area by FLD	Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Hyperaemia area / occlusion area ratio by FLD	Vascular endothelial function in the micro-vascular compartment will be assessed using the ratio hyperaemia area / occlusion area determined by FLD realized between T-30min to T300min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Maximal flow by FLD	Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the maximal flow using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Hyperaemia half time by FLD	Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia half time using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Reactive Hyperemia - Peripheral Arterial Tonometry (RH-PAT)	Reactive hyperemia index (RHI) assessed by reactive hyperemia-peripheral arterial tonometry (RH-PAT) expressed as a percentage measures pulsatile fluctuations in digital volume in response to a reactive hyperaemia induced by the release of a transient occlusion realized between T-30min to T300min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma nitrite dosage	Determination of nitrite plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Urine nitrite dosage	Determination of nitrite urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma nitrate dosage	Determination of nitrate plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Urine nitrate dosage	Determination of nitrate urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma creatinine dosage	Determination of creatinine plasma concentration (µmol/L) (a biomarker of chronic kidney disease) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Urine creatinine dosage	Determination of creatinine urine concentration (µmol/L) (a biomarker of chronic kidney disease) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma malondialdehyde (MDA) dosage	Determination of MDA plasma concentration (nmol/L) (a biomarker of oxidative stress) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Urine malondialdehyde (MDA) dosage	Determination of MDA urine concentration (nmol/L) (a biomarker of oxidative stress) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma asymmetric dimethylarginine (ADMA) dosage	Determination of ADMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Urine asymmetric dimethylarginine (ADMA) dosage	Determination of ADMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma symmetric dimethylarginine (SDMA) dosage	Determination of SDMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Urine symmetric dimethylarginine (SDMA) dosage	Determination of SDMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma acetyl-lysine dosage	Determination of acetyl-lysine plasma concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3)
Urine symmetric acetyl-lysine dosage	Determination of acetyl-lysine urine concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-60min to T250min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma N-epsilon-carboxy-methyl lysine (CML) dosage	Determination of CML plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine N-epsilon-carboxy-methyl lysine (CML) dosage	Determination of CML urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma N-epsilon-carboxy-ethyl lysine (CEL) dosage	Determination of CEL plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine N-epsilon-carboxy-ethyl lysine (CEL) dosage	Determination of CEL urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma alanine dosage	Determination of alanine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine alanine dosage	Determination of alanine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma arginine dosage	Determination of arginine plasma concentration (µmol/L) between T-90min to T360min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine arginine dosage	Determination of arginine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma asparagine dosage	Determination of asparagine plasma concentration (µmol/L) between T-90min to T360min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine asparagine dosage	Determination of asparagine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma aspartic acid dosage	Determination of aspartic acid plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine aspartic acid dosage	Determination of aspartic acid urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma cysteine dosage	Determination of cysteine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine cysteine dosage	Determination of cysteine urine concentration (µmol/L) between T-60min to T250min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma glutamic acid dosage	Determination of glutamic acid plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine glutamic acid dosage	Determination of glutamic acid urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma glutamine dosage	Determination of glutamine plasma concentration (µmol/L) between T-90min to T360min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine glutamine dosage	Determination of glutamine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma glycine dosage	Determination of glycine plasma concentration (µmol/L) between T-90min to T360min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine glycine dosage	Determination of glycine urine concentration (µmol/L) between T-60min to T250min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma histidine dosage	Determination of histidine plasma concentration (µmol/L) between T-90min to T360min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine histidine dosage	Determination of histidine urine concentration (µmol/L) between T-60min to T250min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma isoleucine dosage	Determination of isoleucine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine isoleucine dosage	Determination of isoleucine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma leucine dosage	Determination of leucine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine leucine dosage	Determination of leucine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma lysine dosage	Determination of lysine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine lysine dosage	Determination of lysine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma methionine dosage	Determination of methionine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine methionine dosage	Determination of methionine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma phenylalanine dosage	Determination of phenylalanine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine phenylalanine dosage	Determination of phenylalanine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma proline dosage	Determination of proline plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine proline dosage	Determination of proline urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma serine dosage	Determination of serine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine serine dosage	Determination of serine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma threonine dosage	Determination of threonine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine threonine dosage	Determination of threonine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma tryptophan dosage	Determination of tryptophan plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine tryptophan dosage	Determination of tryptophan urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma tyrosine dosage	Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine tyrosine dosage	Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma valine dosage	Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine valine dosage	Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma Interleukin 6 (IL-6) dosage	Determination of IL-6 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma Interleukin 1 bêta (IL-1β) dosage	Determination of IL-1β plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma Monocyte Chemoattractant Protein-1 (MCP-1) dosage	Determination of MCP-1 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma Tumor Necrosis Factor alpha (TNFα) dosage	Determination of TNFα plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma InterCellular Adhesion Molecule 1 (ICAM-1) dosage	Determination of ICAM-1 plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma E-Selectine dosage	Determination of E-Selectine plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Transcriptome Sequencing of Peripheral Blood Mononuclear Cells	Transcriptomic Analysis to quantify sets of genes involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Metabolome Sequencing of Plasma	Untargeted Metabolomics to identify and quantify molecules involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma Glucose dosage	Determination of glucose plasma concentration (mg/dl) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma triglycerides dosage	Determination of triglycerides plasma concentration (mg/dl) between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma insulin dosage	Determination of insulin plasma concentration (pmol/L) between T-90min to T360min	Day 0 (V1), Day 28 (V2), Day 56 (V3).
blood Peripheral Blood Mononuclear Cells (PBMC) count	Determination of PBMC count (/mm3) and phenotyping between T-90min to T360min.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
PBMC production of Reactive Oxygen Species (ROS)	Assessment of the ROS level (between T-90min to T360min) produced by isolated PBMC following oxidative stress induction.	Day 0 (V1), Day 28 (V2), Day 56 (V3).
Questionnaire of acceptability	Acceptability was assessed by a 9-point time scale where "1" means a very poor acceptability and "9" means a very good acceptability.	Day 0 (V1), Day 28 (V2), Day 56 (V3).

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Endothelial function; Leucine; Nutrition assessment; Arginine; Cysteine; Vegetable proteins; Nutrition physiological phenomena
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Inflammation; Metabolic Syndrome; Disease Susceptibility
• Other Study ID Numbers: RBHP 2021 PICKERING; 2021-A00134-37 (Other Identifier: 2021-A00134-37)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No